Breast prostheses, methods of manufacturing breast prostheses, and methods of treatment using breast prostheses

ABSTRACT

Improved breast prostheses, methods of making breast prostheses, and methods of treatment using such breast prostheses are described.

This application is a continuation of U.S. patent application Ser. No.14/371,291, which was filed on Jul. 9, 2014, which is a 35 U.S.C. § 371national stage filing of International Application NumberPCT/US2013/021012, which was filed on Jan. 10, 2013 and claims priorityunder 35 U.S.C. § 119 to U.S. Provisional Application No. 61/586,391,which was filed on Jan. 13, 2012.

Implantable breast prostheses, such as breast implants and tissueexpanders, are used in a wide range of breast surgical procedures. Theprostheses can be used for breast augmentation, reconstruction, and/orrevision. However, even though the implants and tissue expanders used inbreast surgical procedures are biocompatible and non-reactive,post-surgical complications can result from their use. Complications,including capsular contracture, scar formation, implant displacement,rippling, and palpability of implants result in pain and dissatisfactionwith breast appearance. Research and studies have been conducted toidentify surgical techniques and modified implant characteristics thatresult in reduced incidence of complications.

One approach that surgeons use to improve aesthetic outcomes, reduce therisk of complications, and or provide improved revisions is to use graftmaterials, such as acellular dermal tissue matrices such as ALLODERM® orSTRATTICE™ (LIFECELL CORPORATION, Branchburg, N.J.), along with theimplants or tissue expanders. These tissue matrices can be used tosupport the breast and to act as a tissue extension or tissuereplacement. In addition, by promoting the organization of the healingprocess, the tissue matrices promote regenerative repair rather thanscar formation.

The current standard of care during surgical breast procedures involvesseparately attaching the graft material to the patient and then placingthe prosthesis in the patient. For example, in one procedure the surgeonfirst separately attaches the graft material to the infra mammary fold(IMF) and the pectoralis major muscle in order to create a submuscularpocket or flap. Next, the surgeon places the breast implant or tissueexpander inside the pocket. The entire process of attaching the graftmaterial to the native tissue takes a lot of time and involves the useof many sutures or other devices to anchor the graft material to thenative tissue. The current process can also lead to inconsistentresults, as inexperienced surgeons may not use graft materials ofoptimal shape, or may incorrectly position the implant or tissueexpander relative to the graft material.

Accordingly, there is a need for an improved breast prostheses, methodsof making breast prostheses, and methods of treatment using such breastprostheses.

In accordance with the invention, breast prostheses, methods of makingbreast prostheses, and methods of treatment using such breast prosthesesare provided.

According to certain embodiments, a prosthesis is disclosed thatcomprises a tissue expander and one or more samples of graft materialsized and shaped to conform to a portion of a surface of the tissueexpander, wherein the one or more samples of graft material is attachedto the tissue expander by an adhesive that degrades over time.

According to certain embodiments, a method of making a prosthesis isdisclosed. The method comprises providing a tissue expander and one ormore samples of graft material sized and shaped to conform to a portionof a surface of the breast implant or tissue expander, and attaching theone or more samples of graft material to the tissue expander by anadhesive that degrades over time.

According to certain embodiments, a prosthesis is provided. Theprosthesis comprises a tissue expander and one or more samples of graftmaterial sized and shaped to conform to a portion of a surface of thetissue expander, wherein the tissue expander comprises resorbable tabsor resorbable barbs, and wherein the one or more samples of graftmaterial are attached to the breast implant or tissue expander by theresorbable tabs or resorbable barbs on the breast implant or tissueexpander.

According to certain embodiments, a method of making a prosthesis isprovided. The method comprises providing a tissue expander and one ormore samples of graft material sized and shaped to conform to a portionof a surface of the tissue expander, wherein the tissue expandercomprises resorbable tabs or resorbable barbs, and attaching the one ormore samples of graft material to the tissue expander by the resorbabletabs or resorbable barbs on the tissue expander.

According to certain embodiments, methods of making a device suitablefor use in breast surgical procedures are provided. The methods compriseproviding one or more samples of graft material and forming a pocketfrom the graft material that is sized and shaped to hold a tissueexpander.

According to certain embodiments, methods of making a prosthesis areprovided. The methods comprise providing a tissue expander and one ormore samples of graft material, forming a pocket from the graft materialthat is sized and shaped to hold the breast implant or tissue expander,and inserting the implant into the pocket.

According to certain embodiments, methods of making a prosthesis areprovided. The method comprise preparing a shell of a tissue expander,providing one or more samples of graft material sized and shaped toconform to a portion of a surface of the tissue expander, attaching thegraft material to the outer shell of the tissue expander prior to curingthe shell of the tissue expander, and curing the combined shell of thetissue expander and graft material. In certain embodiments, the methodfurther comprises the step of removing the graft material from theshell.

Furthermore, methods of treatment using the disclosed prostheses areprovided.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of the components of a prosthesisaccording to certain exemplary embodiments.

FIG. 1B is a posterior view of a tissue expander according to certainembodiments.

FIG. 1C is a side view of a tissue expander according to certainembodiments.

FIG. 1D is a posterior view of a tissue expander according to certainembodiments.

FIG. 2 is a perspective view of the components of a prosthesis accordingto certain exemplary embodiments.

FIGS. 3A and 3B show a schematic view of a portion of graft material anda portion of a breast implant or tissue expander, illustrating how thetwo components fit together, according to certain embodiments.

FIGS. 4A, 4B, and 4C show a schematic view a portion of a breast implantor tissue expander, illustrating exemplary shapes of resorbable tabs,according to certain embodiments.

FIG. 5 is a schematic view of a tissue expander, as it expands overtime, according to certain embodiments.

FIG. 6 is a view of a sample of graft material with apertures cut in thegraft material that correspond to the tabs on the tissue expander ofFIG. 5, according to certain embodiments.

FIGS. 7A, 7B, 7C, 7D, 7E, and 7F show a schematic view of a portion ofgraft material and a portion of a tissue expander, illustrating how thetabs on the tissue expander pop out of a smaller hole in the graftmaterial, and fit into the larger hole on the graft material, as thetissue expander expands, according to certain embodiments.

FIG. 8 is a perspective view of the components of a prosthesis,according to certain embodiments.

FIG. 9 is a perspective view of a prosthesis, according to certainexemplary embodiments.

FIGS. 10A and 10B are perspective views of graft material according tocertain exemplary embodiments.

FIGS. 11A and 11B are perspective views of graft materials according tocertain exemplary embodiments.

DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS

Reference will now be made in detail to certain exemplary embodiments ofthe invention, certain examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including,” as well as other forms, such as “includes” and “included,”is not limiting. Any range described herein will be understood toinclude the endpoints and all values between the endpoints. Also, termssuch as “element” or “component” encompass both elements and componentscomprising one unit and elements and components that comprise more thanone subunit, unless specifically stated otherwise. Also, the use of theterm “portion” may include part of a moiety or the entire moiety.

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.All documents, or portions of documents, cited in this application,including but not limited to patents, patent applications, articles,books, and treatises, are hereby expressly incorporated by reference intheir entirety for any purpose.

The term “graft material,” as used herein, generally refers to abiocompatible material such as, for example, tissue, processed tissue,or synthetics that can be attached to or inserted into a bodily part.

The terms “breast implant” and “implant,” as used herein, generallyrefer to medical devices that are implanted either under or withinbreast tissue or under the chest muscle for breast augmentation orreconstruction. Such implants can include saline filled or silicone gelimplants, or other implants that provide volume for breast augmentation.The terms “breast tissue expander” or “tissue expander,” as used herein,generally refer to devices that are implanted under or within breasttissue or chest muscle, and which are expanded over time to stretchbreast tissue and skin. Unless otherwise indicated, implants and tissueexpanders can be used interchangeably with the graft materials, methodsor device of attaching graft materials to implants or expanders, methodsof forming implants or graft materials, and methods of treatment or useof the devices described herein. Furthermore, the term “prosthesis” willbe understood to include any implantable device disclosed herein, whichcomprise an implant and/or tissue expander component.

The present disclosure relates to prostheses, methods of makingprostheses, and methods of treatment using the prostheses. Theprostheses can be used for breast augmentation, reconstruction, orrevision. As such, the implantable prostheses and methods discussedherein may be suitable for a wide range of surgical applications. Invarious embodiments, the prostheses and methods discussed herein may besuitable for various types of surgical breast procedures, such as, forexample, aesthetic surgery associated with mastectomy or lumpectomy,breast reconstruction, breast augmentation, breast enhancement,mastopexy, and revisionary breast surgeries.

According to certain embodiments, a prosthesis is disclosed thatcomprises a breast implant or a tissue expander and one or more samplesof graft material, wherein the implant or tissue expander is attached tothe one or more samples of graft material in a manner that allows theimplant or tissue expander and the one or more samples of graft materialto be implanted in a patient as one unitary prosthesis; and wherein theimplant or tissue expander is attached to the one or more samples ofgraft material in a manner that will allow the implant or tissueexpander and the graft material to be easily separated after a period oftime in vivo.

In certain embodiments, the prosthesis of the present disclosurecomprise tissue expanders. Further, the structure of the tissueexpander, along with its attachment to a graft material such as anacellular tissue matrix, can allow the tissue expander to be enlargedand removed after a certain period of time, without removing the graftmaterial. Accordingly, the devices and methods of the present disclosurecan be beneficial for reconstruction procedures that require removal oftissue expanders.

By providing the implant or tissue expander and the one or more samplesof graft material as one unitary prosthesis, the implantable prosthesesof the present disclosure can shorten procedure time, reduce the numberof surgical sutures and/or staples or other attachment device needed,and reduce the associated costs of surgery. The implantable prosthesescan also improve surgical outcomes and improve consistency of results byleveling the playing field for inexperienced surgeons. The implantableprostheses are believed to reduce the incidence of extrusion andcapsular contraction, to block the inflammatory response, and to resultin shorter expansion times.

However, while in some embodiments the breast implants and tissueexpanders can be implanted as one unitary prosthesis, the implantableprostheses of the present disclosure can be constructed such that thebreast implant or tissue expander is easily separated from the graftmaterial after being implanted in vivo. In various embodiments, thegraft material can be removed from tissue expanders which are designedto be removed from the patient after a period of time, and also forbreast implants, which are sometimes removed from the patient forrevision.

According to certain embodiments, a prosthesis is disclosed thatcomprises a breast implant or tissue expander and one or more samples ofgraft material sized and shaped to conform to a portion of a surface ofthe breast implant or tissue expander, wherein is the one or moresamples of graft material is attached to the breast implant or tissueexpander by an adhesive that degrades over time. In some embodiments,the adhesive can be a synthetic adhesive. Examples of syntheticadhesives include silicone, cyanoacrylates, methyl-ethyl cyanoacrylate,iso(n)butyl-cyanoacrylate (Liquid Bandage Vetbond), octyl-cyanoacrylate(DERMABOND), and Polyethylene glycol (PEG) based associated sealants. Insome embodiments, the adhesive can be a biologically derived glue.Examples of biologically derived adhesives include marine adhesives,fibrin glue, fibrin sealants (TISSEAL, EVICEL, PROFIBRIX), proteinaldehyde sealants (FLOSEAL), mussel adhesive protein,albumin-glutaraldehyde (BIOGLUE).

According to certain embodiments, a method of making a prosthesis isprovided. The method can comprise providing a breast implant or a tissueexpander and one or more samples of graft material sized and shaped toconform to a portion of a surface of the breast implant or tissueexpander, and attaching the one or more samples of graft material to thebreast implant or tissue expander with an adhesive that will degradeover time. In some embodiments, the adhesive can be a syntheticadhesive. Examples of synthetic adhesives include silicone,cyanoacrylates, methyl-ethyl cyanoacrylate, iso(n)butyl-cyanoacrylate(Liquid Bandage Vetbond), octyl-cyanoacrylate (DERMABOND), andPolyethylene glycol (PEG) based associated sealants. In someembodiments, the adhesive can be a biologically derived glue. Examplesof biologically derived adhesives include marine adhesives, fibrin glue,fibrin sealants (TISSEAL, EVICEL, PROFIBRIX), protein aldehyde sealants(FLOSEAL), mussel adhesive protein, albumin-glutaraldehyde (BIOGLUE).

FIG. 1A provides a view of the components of one exemplary embodiment ofan implantable prosthesis 20. FIG. 1A shows a modeled Style 410Anatomical Implant (Allergan, Inc. (Santa Barbara, Calif.)) 22 in avertical orientation and a sample of graft material 21 having a shapeproduced by modeling graft material covering 50% of implant 22 such thatsample of graft material 21 may be bordered by the inframammary fold,the lateral fold, and the inferior edge of the pectoralis major musclewhen implanted in a patient. FIGS. 1A-1C illustrate prostheses 20′comprising tissue expanders 22′ with graft materials 21. The tissueexpanders 22′ can further include suture tabs 23 for attachment of theexpander to tissues.

The implants or expanders can be formed from a variety of suitablematerials. For example, the shell of an expander may be produced from amaterial that is designed to prevent tissue ingrowth and adhesion. Forexample, in some embodiments, the tissue expanders 22′ are formed of asmooth shell, such as smooth silicon. Further, the suture tabs 23 can beformed of a textured materials to allow cellular in-growth, or can beformed of a smooth material (e.g., silicone) that prevents adhesion andallows easy removal of the expander later.

In some embodiments the adhesive can be applied directly to the portionof the breast implant 22 or tissue expander 22′ that will interface withthe graft material 21. In some embodiments the adhesive can be applieddirectly to the portion of the graft material 21 that will interfacewith the breast implant 22 or tissue expander 22′. In some embodimentsthe adhesive can be applied directly to both the portion of the breastimplant 22 or tissue expander 22′ that will interface with the graftmaterial 21, and to the portion of the graft material 21 that willinterface with the breast implant 22 or tissue expander 22′.

In some embodiments, the adhesive can be applied in a spray form over tothe portion of the breast implant 22 or tissue expander 22′ that willinterface with the graft material 21. In some embodiments, the adhesivecan be applied in a spray form over the portion of the graft material 21that will interface with the breast implant 22 or tissue expander 22′.In some embodiments, the adhesive can be applied in a spray form overboth the portion of the breast implant 22 or tissue expander 22′ thatwill interface with the graft material 21, and the portion of the graftmaterial 21 that will interface with the breast implant 22 or tissueexpander 22′.

In some embodiments, the breast implant or tissue expander can beattached to the one or more samples of graft material in a surgicalsetting or the operating room just prior to the prosthesis beingimplanted in the patient. In some embodiments, the breast implant ortissue expander can be attached to the one or more samples of graftmaterial prior to the surgery. In some embodiments, the breast implantor tissue expander can be attached to the one or more samples of graftmaterial prior to the surgery, so that the implantable prosthesis can besold as a ready-to-use, off the shelf prosthesis.

According to certain embodiments, a prosthesis is disclosed thatcomprises a breast implant or tissue expander and one or more samples ofgraft material sized and shaped to conform to a portion of a surface ofthe breast implant or tissue expander, wherein the breast implant ortissue expander comprises resorbable tabs or resorbable barbs, andwherein the one or more samples of graft material are attached to thebreast implant or tissue expander by the resorbable tabs or resorbablebarbs on the breast implant or tissue expander. In various embodiments,the resorbable polymers can comprise aliphatic polyester polymers,copolymers, blends thereof, polymers of lactide, galactide, orcopolymers thereof, polysaccharides such as cellulose, and oxidizedpolysaccharides, or other absorbable polymers.

FIG. 2 shows a breast implant 20 in a vertical orientation and a sampleof graft material 21. The implant 20 comprises tabs 23. The graftmaterial 21 comprises corresponding apertures 24, so that the graftmaterial can be attached to the implant. FIGS. 3A and 3B depict aschematic view of a portion of the implant 20, resorbable tabs 23, graftmaterial 21, and apertures 24. The tabs can be of any geometrical shapethat will engage the graft material. FIGS. 4A, 4B, and 4C show aschematic view a portion of a breast implant, illustrating that the tabsmay be circular 25, squared 26, or in the shape of a button 27. In someembodiments, the tabs are placed in a straight line. In someembodiments, the tabs are placed in a non-linear pattern. Furthermore,FIGS. 1A-1C illustrates tissue expanders 21′ tabs 40, 41 and openings 42having configurations that may be used with any of the implants ortissue expanders provided herein.

FIG. 5 depicts an exemplary embodiment of a tissue expander 28 a thatcomprises tabs 29 a. Over time the tissue expander expands 28 b, and thetabs, being located on the surface of the tissue expander, also move toa positio 29 b. FIG. 6 depicts a top view of a sample of graft material30 with apertures 31 cut to leave room for the tissue expander tabs topop out of the smaller holes and to engage in the larger holes as thetissue expander and tabs expand, as described, for example, withreference to FIG. 5.

FIGS. 7A-7C depict a schematic side view of a portion of a tissueexpander 28 a and graft material 30. Over time, as the tissue expandervolume increases 28 b (FIG. 7B) and 28 c (FIG. 7C), the location of thetabs increases 29 b and 29 c, and the tissue expander tab 29 a pops outof the smaller hole 31 a, and attaches firmly to the larger hole 31 b.Further, in certain embodiments, as shown in FIGS. 7D-7F, the expander28 can have tabs 29, 29′ of differing sizes, which can accommodatediffering sizes of apertures 31, which may stretch or enlarge as thetissue expanding enlarges.

In some exemplary embodiments, the graft material does not compriseapertures, and the graft material is attached to the resorbable tabs bybiodegradable sutures, adhesives that degrade over time, or any means ofattachment known by one of skill in the art.

In some embodiments, the implant or tissue expander comprises resorbablebarbs. FIGS. 8 and 9 depict exemplary embodiments, wherein the implant20 or tissue expander comprises resorbable barbs 32, which attach toslits 33 (FIG. 8) or mesh 34 (FIG. 9) on the graft material.

According to certain embodiments, a method of making an implantableprosthesis is disclosed. The method can comprise providing a breastimplant or tissue expander and one or more samples of graft materialsized and shaped to conform to a portion of a surface of the breastimplant or tissue expander, wherein the breast implant or tissueexpander comprises resorbable tabs or resorbable barbs, and attachingthe one or more samples of graft material to the breast implant ortissue expander by the resorbable tabs or resorbable barbs on the breastimplant or tissue expander.

In some embodiments, the breast implant or tissue expander can beattached to the one or more samples of graft material in a surgicalsetting or the operation room just prior to insertion. In someembodiments the breast implant or tissue expander can be attached to theone or more samples of graft material prior to the surgery. In someembodiments the breast implant or tissue expander can be attached to theone or more samples of graft material prior to the surgery, so that theimplantable prosthesis can be sold as a ready-to-use, off the shelfprosthesis.

According to certain embodiments, methods of making a device suitablefor use in breast surgical procedures are disclosed comprising providingone or more samples of graft material and forming a pocket from thegraft material that is sized and shaped to hold a breast implant ortissue expander.

FIGS. 10A and 10B illustrate the components of one exemplary embodiment.According to certain embodiments, the pocket may be formed by cutting aslit through the thickness 35 of the graft material 36, forming a pocket37 with an open end 38. FIGS. 11A and 11B illustrate the components ofanother exemplary embodiment. According to certain embodiments, thepocket may be formed by cutting two portions of graft material 36 andattaching the portion with an adhesive, sutures, or any other meansknown to one of skill in the art to form a pocket 37 with an open end38.

In some embodiments, the pocket further comprises suture tabs 39, forattachment of the pocket to the chest wall.

According to certain embodiments, methods of making a prosthesis aredisclosed comprising providing a breast implant or tissue expander andone or more samples of graft material, forming a pocket from the graftmaterial that is sized and shaped to hold the breast implant or tissueexpander, and inserting the implant into the pocket.

According to certain embodiments, methods of making a prosthesis aredisclosed comprising preparing the shell of a silicone breast implant orsilicone tissue expander, providing one or more samples of graftmaterial sized and shaped to conform to a portion of a surface of abreast implant or tissue expander, attaching the graft material to theshell of the breast implant prior to curing the shell of the siliconebreast implant or silicone tissue expander, and curing the shell of thebreast implant or tissue expander and the graft material.

In some embodiments the graft material is an acellular tissue matrix. Insome embodiments the shell of the breast implant or tissue expander andthe acellular tissue matrix are cured such that the curing temperaturedoes not reach a temperature greater than 30° C. In some embodiments theshell of the breast implant or tissue expander and the acellular tissuematrix are cured such that the curing temperature does not exceed 25° C.

In some embodiments the graft material is an adipose extracellulartissue matrix protein that has been treated to produce athree-dimensional porous, or sponge-like material. In some embodimentsthe shell of the breast implant or tissue expander and the adiposeextracellular tissue matrix are cured such that the curing temperatureis between 70° C. to 120° C., or between 80° C. to 110° C., or to about100° C. In some embodiments lower or higher temperatures could be usedas long as melting of the matrix proteins does not occur.

In certain embodiments the method of making a prosthesis furthercomprises the step of removing the graft material from the shell afterthe curing step but prior to implanting the prosthesis. This stepresults in a silicone breast implant or tissue expander with the textureof the graft material impressed on the implant.

The various embodiments of implantable prostheses discussed hereininclude a sample of graft material. The graft materials discussed hereininclude a sample of biocompatible material. The samples of biocompatiblematerial can comprise any suitable synthetic or biologic material, suchas, for example, medical grade silicon, autologous or cadaveric tissue,and/or biomatrices, such as, for example, an acellular tissue matrix(“ATM”). In some embodiments, the sample of biocompatible material maybe a flat sheet or sheet-like in form. A sample of biocompatiblematerial may be a single layer or may be multi-layered. In someembodiments, a sample of biocompatible material may be a material thatfacilitates revascularization and cell repopulation. For example,certain embodiments can include an acellular tissue matrix (“ATM”).

As used herein, ATM refers to a tissue-derived biomatrix structure thatcan be made from any of a wide range of collagen-containing tissues byremoving all, or substantially all, viable cells and all detectablesubcellular components and/or debris generated by killing cells. As usedherein, an ATM lacking “substantially all viable cells” is an ATM inwhich the concentration of viable cells is less than 1% (e.g., lessthan: 0.1%; 0.01%; 0.001%; 0.0001%; 0.00001%; or 0.000001%) of that inthe tissue or organ from which the ATM was made.

In some embodiments the ATM is treated to produce a three-dimensionalporous, or sponge-like material.

For a description of ATMs that are suitable for use in the presentdisclosure, as well as methods of making ATMs, see copending U.S.application Ser. No. 12/506,839 (published as US 2011/0022171) atparagraphs 41-73 and U.S. Provisional Application No. 61/491,787 atparagraphs 23-38 and 42-56. The disclosure of both applications isincorporated herein by reference in their entirety. Additionally, asnon-limiting examples of methods of producing ATMs, mention is made ofthe methods described in U.S. Pat. Nos. 4,865,871; 5,366,616; and6,933,326, and U.S. Patent Application Publication Nos. US2003/0035843A1, and US 2005/0028228 A1, all of which are incorporated herein byreference in their entirety.

In some embodiments, the graft material comprises STRATTICE™, a porcinedermal tissue produced by Lifecell Corporation (Branchburg, N.J.). Insome embodiments, the graft material comprises ALLODERM®, an ATMproduced from human dermis by the LifeCell Corporation (Branchburg,N.J.).

In some embodiments, the graft material comprises an adipose tissuematrix. In some embodiments the graft material is an adiposeextracellular tissue matrix protein that has been treated to produce athree-dimensional porous, or sponge-like material. For a description ofadipose tissue matrices that are suitable for use in the presentdisclosure, as well as methods of making adipose tissue matrices, seeU.S. Provisional Application No. 61/491,787 at paragraphs 23-38 and42-56. Briefly, the process generally includes obtaining adipose tissue,mechanically processing the adipose tissue to produce small pieces,further processing the tissue to remove substantially all cellularmaterial and/or lipids from the tissue, resuspending the tissue in asolution to form a porous matrix or sponge, and cross-linking the tissueto produce a stable three-dimensional structure.

In certain embodiments, ready-to-use, off-the-shelf graft materials thatare designed to conform to breast implants of various specifications canbe used. For a description of methods of making graft materials that aresized and shaped to conform to a portion of a surface of the breastimplant and are suitable for use in the present disclosure, seecopending U.S. application Ser. No. 12/506,839 (published as US2011/0022171). The disclosure of U.S. application Ser. No. 12/506,839 isincorporated herein by reference in its entirety.

In certain embodiments, methods of treatment are provided comprisingproviding any one of the breast prostheses described above; andimplanting the breast prosthesis into a site on a patient where a breastprosthesis is required.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A breast prosthesis comprising: a tissue expanderor a breast implant; and one or more samples of graft material, whereinthe one or more samples of graft material are attached to the tissueexpander or breast implant with an adhesive that degrades over time,wherein the adhesive is selected from a group consisting of at least oneof silicone, poly(methyl methacrylate), a marine adhesive, orcombinations thereof, and wherein the graft material comprises anacellular adipose tissue matrix.
 2. The breast prosthesis of claim 1,wherein the acellular adipose tissue matrix has been treated to producea three-dimensional porous or sponge-like material.
 3. The breastprosthesis of claim 1, wherein the tissue expander or breast implantcomprises a saline filled implant.
 4. The breast prosthesis of claim 1,wherein the tissue expander or breast implant comprises a silicone gelimplant.
 5. A method of making a breast prosthesis comprising: selectinga tissue expander or a breast implant; selecting one or more samples ofgraft material comprising an acellular adipose tissue matrix; andattaching the one or more samples of graft material to the tissueexpander or breast implant with an adhesive that will degrade over timewhen implanted in vivo, wherein the adhesive is selected from a groupconsisting of at least one of silicone, poly(methyl methacrylate), amarine adhesive, or combinations thereof.
 6. The method of claim 5,wherein the acellular adipose tissue matrix has been treated to producea three-dimensional porous or sponge-like material.
 7. The method ofclaim 5, wherein the tissue expander or breast implant comprises asaline filled implant.
 8. The method of claim 5, wherein the tissueexpander or breast implant comprises a silicone gel implant.
 9. A breastprosthesis comprising: a tissue expander or a breast implant; and one ormore samples of graft material, wherein the one or more samples of graftmaterial are attached to the tissue expander or breast implant with anadhesive that degrades over time, wherein the graft material comprisesan extracellular tissue matrix, and wherein the extracellular tissuematrix has been treated to produce a three-dimensional porous orsponge-like material.
 10. The breast prosthesis of claim 9, wherein thetissue expander or breast implant comprises a saline filled implant. 11.The breast prosthesis of claim 9, wherein the tissue expander or breastimplant comprises a silicone gel implant.
 12. The breast prosthesis ofclaim 9, wherein the graft material comprises an acellular tissuematrix.
 13. The breast prosthesis of claim 12, wherein the acellulartissue matrix comprises a dermal tissue matrix.
 14. The breastprosthesis of claim 12, wherein the acellular tissue matrix comprises anadipose tissue matrix.
 15. A method of making a breast prosthesiscomprising: selecting a tissue expander or a breast implant; selectingone or more samples of graft material comprising an extracellular tissuematrix, wherein the extracellular tissue matrix has been treated toproduce a three-dimensional porous or sponge-like material; andattaching the one or more samples of graft material to the tissueexpander or breast implant with an adhesive that will degrade over timewhen implanted in vivo.
 16. The method of claim 15, wherein the tissueexpander or breast implant comprises a saline filled implant.
 17. Themethod of claim 15, wherein the tissue expander or breast implantcomprises a silicone gel implant.
 18. The method of claim 15, whereinthe graft material comprises an acellular tissue matrix.
 19. The methodof claim 18, wherein the acellular tissue matrix comprises a dermaltissue matrix.
 20. The method of claim 19, wherein the acellular tissuematrix comprises an adipose tissue matrix.